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GE HealthCare is looking to ensure the fulfillment of internal and external requirements for medical devices and pharmaceutical products distributed by PDx, ensuring that projects and products meet specified standards and maintain quality and regulatory compliance.

Requirements

• Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP).
• Hands-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements.

Responsibilities

• Creates a Quality culture by driving compliance activities around a Life Sciences product, site or region.
• Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
• Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820,ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP).
• Hands-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements.
• Developing in-depth knowledge of a discipline.
• The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures.

Other

• At least 3 years of relevant experience in Quality Assurance or Quality Engineering in the pharmaceutical or medical device industry.
• Ability to work with cross-functional teams in a global matrix organization.
• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.